BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 2153561 · Received July 7, 2011

    Report

    Report Number
    2124215-2011-06213
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 7, 2011
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    NVZ
    PMA / PMN Number
    D970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE EXHIBITED VARYING BATTERY STATUS MEASUREMENTS BETWEEN ELECTIVE REPLACEMENT NEAR (ERN) AND BEGINNING OF LIFE (BOL). THE HEALTH CARE PROVIDER CONSULTED TECHNICAL SERVICES (TS) AND DISCUSSED THE EXPECTED DEVICE BATTERY STATUS WHEN NEARING END OF LIFE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT PUERTO RICO BV 1298

    Patients

    Seq Age Sex Outcome Treatment
    1